MeiraGTx has designed, built, and registered with the Medicines and Healthcare Products Regulatory Agency (MHRA) a cGMP manufacturing facility. The 29,000-square foot facility is located in central London and comprises of cell expansion, bulk production virus suites, fill and finish and quality control laboratories, and is designed for the manufacture of gene therapies in a fully integrated manner. The design of the HVAC systems and the use of novel pressure bubble concepts for the air handling regimes fosters the facility’s multi-product capability for up to three different product targets to be manufactured in parallel. The production rooms all have independent utilities that stand alone and aim to provide maximum containment between products, viruses and personnel. The facility was designed to accommodate planar and bioreactor production platforms with the ability to implement robotics at the fill and finish stage of the product manufacture. The facility provides an important strategic tool by which MeiraGTx plans to support and control the manufacture of clinical and commercial supply of innovative gene therapy product candidates from pre-clinical stages through clinical trials and potential commercialization.
In addition to a state-of-the-art manufacturing facility, the company has designed and purpose-built a research and development laboratory under the same roof, allowing the company to develop novel processes, methods and analytical techniques, and transfer them to the [c]GMP core using our in-house staff throughout the procedure. The ability for MeiraGTx to develop processes and train their own staff is aimed to ensure that the experience gained during process development is retained within the company, a key part of our integrated vision.
Our manufacturing team consists of more than 40 highly trained multidisciplinary staff with backgrounds in manufacturing, managing and delivering gene therapy products.
“Gene therapy is a next-generation medicine that requires novel manufacturing technologies in order to be both flexible and scalable. Flexibility allows us to take our process and apply it to new medicines and address markets that we previously would not have been able. The efficiency and simplified scale-up allow for shorter production time and increases our ability to potentially help a greater number of patients.”
– Stuart Naylor, Ph.D., Chief Development Officer